On March 21, 2023, Sandoz, announced FDA approval of its citrate-free high-concentration formulation (HCF) of its biosimilar HYRIMOZ® (adalimumab-adaz) injection. HYRIMOZ® is approved to treat seven indications covered by the reference medicine, HUMIRA® (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Sandoz announced that it intends to launch the HYRIMOZ® citrate-free HCF in the U.S. on July 1, 2023.
Sandoz’s announcement follows Amgen’s launch of its own biosimilar to HUMIRA®, AMJEVITA® (adalimumab-atto), which we reported on earlier this year.